President Clinton is challenging scientists to improve the safety of experimental gene therapy or risk the future of their programs.
"If we don't have full confidence in these trials, people won't participate, and then the true promise of genetic medicine will be put on hold," Clinton said Tuesday in a speech to the American Association for the Advancement of Science in Washington.
Also on Tuesday, Clinton signed an executive order barring federal agencies from using genetic information to discriminate against their employees.
"Like many Americans, I have been extremely concerned about reports that some families involved in trials of experimental gene therapies have not been fully informed of the risks and that some scientists have failed to report serious side-effects from these trials," Clinton said.
The death of 18-year-old Jesse Gelsinger at the University of Pennsylvania in September prompted an inquiry by the FDA and led to the suspension of eight gene therapy experiments at the university.
Clinton said he has asked Secretary of Health and Human Services Donna Shalala to instruct the FDA and the National Institutes of Health (NIH) to "accelerate their review of gene therapy and guidelines."
The NIH declined to comment on the president's announcement, and FDA officials also were unavailable.
At a Senate hearing last week, Gelsinger's father testified that researchers lead him to believe that they had seen improvement in one experimental patient, while a report clearly said they had not.
The teen-ager was undergoing an experimental therapy that introduced a healthy gene into his body in an attempt to find a treatment for a rare liver disorder.
"I want to know how we can better ensure that this information about the trials is shared with the public," Clinton said. "I want to know whether we need to strengthen requirements on informed consent."
Beth Israel Deaconess hospital in Boston also shut down a gene therapy program this week, The Associated Press reported Tuesday.
Clinton did not suggest that new legislation should be written to regulate gene therapy, which some experts agree would be a mistake.
Cyrus Harmon, president and CEO of Neomorphic, a genomics company in Berkeley, California, said he's worried about a possible overreaction to the problems at the Penn gene therapy lab.
"People are always at a risk in any sort of trials," Harmon said. "But I don't see it as fundamentally more risky than [treatments using] small molecules or proteins. Those kinds of therapies can kill you just as quickly.
"Asking these kinds of questions is a good thing, but legislation passed in an effort to fix the problem would be the wrong way to do it," he said.
Harmon said that the infrastructure that's in place for all clinical trials should work just as well for gene therapy experiments.
"To ban gene therapy trials would be a travesty," he said, echoing Clinton's comments.
"We cannot allow our remarkable progress in genomic research to be undermined by concerns over the privacy of genetic data or the safety of gene therapies," Clinton said.
